Kornimate/medical-research-clean huggingface dataset:
study to determine the onset of action of indacaterol in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure * patients with a diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the gold guidelines, 2006) and: * smoking history of at least 20 pack years * post-bronchodilator forced expiratory volume in 1 second (fev1) \<80% and ≥30% of the predicted normal value. * post-bronchodilator fev1/forced vital capacity (fvc) \< 70%, where fvc is forced vital capacity ('post-' refers to 15-30 minutes after inhalation of 400 μg of salbutamol at visit 2) exclusion criteria: * pregnant / nursing women or women of child-bearing potential * long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia * patients hospitalized for copd exacerbation in 6 weeks prior to visit 2 and up to visit 3 * respiratory tract infection within 6 weeks prior to visit 2 and up to visit 3 * concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis * any history of asthma, including: blood eosinophil count \>400/mm3; onset of asthma symptoms prior to age 40 years * history of long qt syndrome or whose qtc (bazett's) measured at visit 2 or visit 3 is prolonged (\>450ms for males or \>470ms for females) * clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable af), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study * uncontrolled type i / type ii diabetes or blood glucose outside normal or hba1c \>8.0% of total hemoglobin measured at visit 2 * any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time * history of hypersensitivity to any of the study drugs * irregular day/night, waking/sleeping cycles e.g. shift workers * live attenuated vaccinations within 30 days prior to visit 2 * investigational drug within 30 days prior to visit 2 * known history of non-compliance or not able to use devices or perform spirometry other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease copd indacaterol adults
reverse transcriptase inhibitors in aicardi goutières syndrome

Conditions: Aicardi Goutières Syndrome

Summary: the overall objectives are to explore the safety and efficacy of reverse transcriptase inhibitors tenofovir (tdf)/ emtricitabine (ftc) administered in ags affected children 2 to 18 years of age.

the investigators propose that a trial to assess the proof of principle that antiretroviral therapy through a drug combination of tenofovir (tdf) and emtricitabine (ftc) can decrease endogenous retroelement accumulation, and alter interferon signaling in aicardi goutières syndrome (ags) patients is reasonable and warranted at this time, based on existing in vitro and animal data. additionally, this trial will further the investigators understanding of this disorder, measuring for the first time retroelements in human participants, exploring the retroviral burden in cerebrospinal fluid (csf), the interferon (ifn) signaling response, as well as evaluating antigen targets of autoimmunity and cytokines. if successful, this approach will clearly demonstrate the need for a larger trial of antiretrovirals in ags with more clinically relevant outcomes.

Eligibility criteria:
inclusion criteria: * molecular, neuroimaging, and clinical findings consistent with a diagnosis of ags, with the exception of double-stranded rna-specific adenosine deaminase (adar1) and ifih1, which are not postulated to result in nucleic acid accumulation * evidence of interferon activation such as elevation of csf neopterin/tetrahydrobiopterin measured on the first evaluation. * ages 2-18 years (the age of 2 years is used because the drugs are fda approved in children greater than 2 years) * weight of at least 10 kg * willingness to undergo serial lumbar punctures and blow draws for evaluation of laboratory based outcome measures * willingness to abstain from initiating the use of immune modulating therapies including corticosteroids * able to receive medications orally, by nasogastric (ng) tube or by gastric (g)-tube * no concomitant illness which would preclude safe participation as judged by the investigator * signed informed consent by the subject's legally acceptable representative * negative testing for hiv * negative testing for hepatitis b * concurrent enrollment in the myelin disorders biorepository project (mdbp, clinicaltrials.gov nct03047369) and willingness to undergo associated procedures exclusion criteria: * age \ 18 years * hepatic insufficiency with liver function tests greater than 3-times the upper limit of normal * renal insufficiency with creatinine clearance \<60 * significant malabsorption * any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the subject at an additional risk by participating in this study * hiv infection * hepatitis b infection * mutations in adar1 or ifih1

Keywords: leukodystrophy antiretroviral drugs
safety/efficacy of combo therapy with aliskiren & hydrochlorothiazide vs therapy with hydrochlorothiazide alone in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (hctz) 150/25 mg and 300/25 mg compared with hctz 25 mg in patients with hypertension who do not show response to hctz 25 mg over a 4-week period.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years old or older. * patients with a diagnosis of hypertension defined as follows: * newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp \>= mmhg and \< 110 mmhg at visit 1. * all patients who have been treated for hypertension within the 4 weeks prior to visit 1 must have a msdbp \>= 85 mmhg and \< 110 mmhg at visit 2. * all patients must have a msdbp \>= 90 mmhg and \< 110 mmhg at visit 5. * patients who are eligible and consent to participate in the study exclusion criteria: * severe hypertension (msdbp \>= 110 mmhg and/or mssbp \>=180 mmhg). * previous or current diagnosis of heart failure. * history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: diastolic systolic hypertension aliskiren blood pressure hydrochlorothiazide hctz
carbon monoxide intoxication in korea: prospective cohort (care co cohort)

Conditions: Carbon Monoxide Poisoning; Myocardial Injury; Neurologic Deficits; Image, Body; Therapy; Prognostic Factors; Complications

Summary: this prospective cohort study enrolls subjects who experience carbon monoxide (co) poisoning. the purpose of the study is to evaluate therapeutic effects of various treatments and short and long-term outcomes in co poisoned patients. in addition, complications of brain and heart susceptible to co are investigated through various ways and the association between complications and the patient's prognosis is also investigated. all subjects will be regularly monitored by physicians participating in this study.

this prospective cohort study enrolls subjects who experience co poisoning. the purpose of the study is to evaluate therapeutic effects of various treatments, including hyperbaric oxygen therapy (hbo), therapeutic hypothermia (th), and additional drugs, and short and long-term outcomes, such as neurocognitive sequelae or mortality, in co poisoned patients. in addition, complications of brain and heart susceptible to co are investigated through a variety of ways, such as magnetic resonance image (mri), computed tomography (ct), ultrasound, and laboratory test, and the association between various complications and the patient's prognosis is also investigated. all subjects will be regularly monitored by physicians participating in this study.

Eligibility criteria:
inclusion criteria: * acute co poisoning exclusion criteria: * declined to enrollment in the study
diabetes mellitus at the university medical center of mannheim

Conditions: Diabetes Mellitus; Hypoglycaemia

Summary: development of a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with diabetes. primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. hereby we can derive the effects of staff training on the quality of health care in this patient population.

the prevalence of diabetes in in-patients is about 32% and therefore exceeds significantly the prevalence in general population. in most cases diabetes is only a secondary diagnosis the medical staff has to deal with daily. the diagnosis which leads to hospital admission and the often multiple comorbidities complicate the metabolic control. blood sugar imbalances present an additional risk for these patients and increase in-hospital mortality, length of hospital stay and general complications as nosocomial infections. to improve hospital care for diabetics the endocrine society and the american college of physicians published new guidelines on blood glucose management for non-icu wards. primarily they contain recommendations for blood glucose target range and standards to improve inpatient hospital care like standard operating procedures for blood glucose monitoring as well as hyper- and hypoglycaemic disturbances through to discharge management. we developed a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with diabetes. primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. hereby we can derive the effects of staff training on the quality of health care in this patient population. so far there was only one comparable study published which showed a significant improvement of treatment quality by reducing hypoglycaemia rates considerably . the results of this study cannot be transferred due to substantial structural differences. more over there are no national diabetes management guidelines for inpatient treatment in germany. the following data will be collected: * anthropometric data (age, sex, bodyweight, height) * diagnosis * poct blood glucose values * other laboratory values * length of hospital stay this study conforms to the requirements of the declaration of helsinki, revision of 1996.

Eligibility criteria:
inclusion criteria: * diabetes mellitus exclusion criteria: * age \<18 years

Keywords: diabetes mellitus hypoglycaemia staff training education blood glucose
investigating micro-manipulation procedures for assisted hatching timing

Conditions: Infertility

Summary: this study aims to assess the clinical significance of cleavage stage (day 3) assisted hatching compared to assisted hatching at the blastocyst stage (day 5,6,7) of embryo development at the time of trophectoderm (te) biopsy for patients undergoing in vitro fertilization (ivf) and preimplantation genetic testing for aneuploidy (pgt-a) for treatment of their infertility.

the proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2pns) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.

Eligibility criteria:
inclusion criteria for participants: 1. patients undergoing an ivf cycle with plan for subsequent fet of a single euploid embryo 2. \<4 2pns prior to randomization 3. female partners age \<42 years old at start of vor cycle 4. normal ovarian reserve: 1. amh ≥ 1.2 ng/ml 2. afc ≥ 8 3. fsh ≤ 12iu/l 5. bmi \<38 6. patients who desire to transfer the best quality embryo for their embryo transfer. exclusion criteria for participants: 1. all patients who do not voluntarily give their written consent for participation 2. patients with a prior failed ivf cycle - defined as no blastocysts 3. patients with a history of more than one failed euploid embryo transfer 4. donor oocyte cycles 5. gestational carriers 6. male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 7. use of surgical procedures to obtain sperm 8. communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer 9. endometrial insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid 10. single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard pgt-a
impact of the pharmaceutical care on the quality of life in patients with chagas heart disease

Conditions: Chagas Heart Disease

Summary: the investigators hypothesize that pharmaceutical care may constitute an important tool for the clinical management of these patients by improving their compliance to their treatment with consequent improvement in their quality of life by minimizing symptoms, and decreasing the number of hospital admissions and adverse drug reactions. therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with chagas heart disease complicated by heart failure. study type: interventional study design: a total of 88 patients will be randomly assigned into two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. both groups will be subjected to a follow-up period of 12 months. the primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the minnesota living with heart failure questionnaire. secondary outcomes include drug-related problems and exercise tolerance measured by the standard six-minute walk test.


Eligibility criteria:
inclusion criteria: * the proposed clinical trial will be conducted in volunteers with chagas disease complicated by heart failure. * subjects will include adults, men and women, racial or ethnic minorities. * diagnosed by two distinct chagas serology tests (indirect immunofluorescence and enzyme linked immunosorbent assay exclusion criteria: * patients with any of comorbidities that significantly affect the cardiac performance, such as coronary artery disease, moderate or severe heart valvular disease, left ventricular (lv) hypertrophy, congenital heart disease, or that limit their survival, such as malignant tumors and hiv, will be excluded from the study. * patients will be also be excluded in case of failure to give informed consent, inability to perform 6 minute- walk test, significant cognitive impairment, or pregnancy. * individuals who are participating in others intervention trials will also be excluded.
femoral cartilage thickness in patients with lower limb amputation

Conditions: Amputation; Osteo Arthritis Knee

Summary: the aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

in this prospective observational study, subjects approached tertiary rehabilitation clinics for prothesis recipe or long term outpatient follow up was 150 people. among them 76 subjects accepted to enroll study. informed consent was taken. subjects firstly performed clinical parameters at the first doctor's control. knee radiography has been performed.

Eligibility criteria:
inclusion criteria: * being a single lower limb amputation * at least one year after the amputation operation * prosthesis use for the last 6 months * being traumatic or vascular * not having stump infection * muscle strength over stump should be at least 3/5 exclusion criteria: * doing quadriceps exercise in the last 3 months * trauma, surgery, and knee injections within 6 months (prp, hyaluronic acid), chondroitin-glucosamine use. being any of the active synovitides, rheumatoid arthritis, spondyloarthritis, pseudogout, coxarthrosis, neuromuscular diseases * having an additional disease that will cause psychiatric adjustment problem * subjects are younger than 18 years * bilateral amputated

Keywords: amputate rehabilitation ultrasonography osteoarthritis
evaluation of the safety and tolerability of a higher potency dose of an investigational vaccine among adults 50 years of age and older (v211-009)

Conditions: Healthy

Summary: this study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.


Eligibility criteria:
inclusion criteria: * healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster exclusion criteria : * preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
gynecology beyond gender: cervical cancer screening in transgender men in france

Conditions: Cervical Cancer; Transgender Persons; Health Services for Transgender Persons

Summary: in france, cervical cancer screening is the subject of a national screening programme organized for all asymptomatic individuals aged 25 to 65 years with a cervix. the latter contributes greatly to the prevention and early treatment of this disease, whose public health challenge is recognized worldwide. one of the objectives of this programme is to reduce inequalities in access. transgender men, i.e. individuals assigned to the female gender at birth but identifying with the male gender, are concerned by this screening as long as they still have a cervix, according to the same modalities as for cisgender women. however, they are often excluded from health care, including organized screening programs. gender change in civil status is one of the obstacles. the provision of gynaecological care is sometimes inadequate. the lack of knowledge of health professionals and the problems of discrimination that transgender people may face reduce the chances of having equitable access. this survey aims to explore the perception that transgender men have of cervical cancer screening and to identify the challenges they face, the obstacles and the levers to access this prevention program.


Eligibility criteria:
inclusion criteria: * transgender male (assigned female at birth but identifying as male) * aged 25 to 65 years * having retained her cervix * having had sex before. exclusion criteria: * under 25 and over 65 * not having retained his cervix * history of cancerous lesion of the cervix
99mtc-cndg injection in the diagnosis of malignant tumors

Conditions: Malignant Tumor

Summary: currently, 18f-fluorodeoxyglucose (18f-fdg) is the most widely used tumor imaging agent in clinical practice. however, the production of 18f requires accelerators and is associated with relatively high diagnostic costs, which to some extent limits its widespread clinical application. in comparison to positron emission tomography (pet), single photon emission computed tomography (spect) devices are more abundant and offer lower diagnostic expenses. with the utilization of cadmium zinc telluride (czt) crystals in spect and advancements in image reconstruction techniques, the resolution and sensitivity of spect is continually improving. therefore, the development of a simplified and cost-effective novel spect tumor imaging agent holds significant practical significance. this study involved the design and synthesis of a glucose-derived ligand with a linker containing seven methylene units and an isonitrile group (cn7dg). the cn7dg ligand was labeled with 99mtc to prepare a more lipophilic 99mtc-cn7dg complex, aiming to investigate a novel spect imaging agent for tumor imaging.


Eligibility criteria:
inclusion criteria: * 18-70 years old * patients diagnosed with malignant glioma, colorectal cancer, pancreatic cancer, lung cancer, breast cancer, or other malignant tumors through imaging techniques such as mri, ct, and ultrasound, and who are scheduled for surgical resection or biopsy * solid tumor sizes greater than 2cm * voluntarily agree to participate and sign an informed consent form * can provide complete surgical records, pathological results, control data, and clinical follow-up results exclusion criteria: * pre-treatment such as chemotherapy and targeted therapy has been administered * pregnancy and breastfeeding * claustrophobia * the condition is severe and difficult to cooperate with * unable to obtain relevant control imaging data and clinical information
esketamine combined with pregabalin on cpsp in spinal patients.

Conditions: Esketamine; Pregabaline; Chronic Post Operative Pain

Summary: chronic postsurgical pain has become one of the most common complications of surgery. the quality of life will be impacted once the postsurgical patients are combined with persistent pain. what's more, the postsurgical pain may increase other adverse outcomes. it's important to find a better way to keep the postsurgical patients away from postoperative pain. esketamine and pregabalin have become potentially effective drugs on cpsp.


Eligibility criteria:
inclusion criteria: * patient undergoing elective primary spinal tumor surgery; * ages between 18 and 65 years old; * american society of anaesthesiology (asa) status i-iii; * signed informed consent. exclusion criteria: * previous adverse reaction to ketamine, s-ketamine or pregabalin; * patients with a diagnosed history of severe chronic pain; * patients with long-term analgesic treatment(gabapentin/opioids/ketamine); * patients with aphasia or inability to cooperate with the pain assessments; * known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); * patients with a diagnosed history of psychiatric disorder; * patients treated with gabapentin/pregabalin in the last three months; * drug abuse; * body mass index (bmi) \> 35 kg/m2 ; * pregnancy or lactation.